Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH) (SSIHLVER)

Prospective Descriptive Multicentre Pilot Study On The Effectiveness and Safety Of Optilene® Silver Mesh Elastic In Prevention Of Surgical Site Infection (SSI) And Incisional Hernia (IH)

The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on the SSI rates, IH rates and overall clinical performance of Optilene® Silver Mesh Elastic used for the prevention of incisional hernia as prophylactic mesh in patients that require urgent median laparotomy in clinical routine.

Study Overview

• Status: Not yet recruiting
• Conditions: Morbid Obesity; Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Prophylactic mesh

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Irene Fita Esteban; Phone Number: +34609054401; Email: info@bbraun.com
• Study Contact Backup: Name: José Manuel Molina Villar; Phone Number: +34697502623; Email: info@bbraun.com

Study Locations

• Spain
  • Badalona, Spain, 08916
    • Hospital Universitari Germans Tries i Pujol
    • Contact: Joan Francesc Julián, Dr.
    • Principal Investigator: Joan Francesc Julián, Dr.
  • Badalona, Spain
    • Hospital Municipal Badalona
    • Contact: Jorge Marroquin, Dr.
    • Principal Investigator: Jorge Marroquin, Dr.
  • Calella, Spain, 08370
    • Hospital Comarcal Sant Jaume de Calella
    • Contact: Paqui Vasco, Dr.
    • Principal Investigator: Paqui Vasco, Dr.
  • Mataró, Spain, 08304
    • Hospital de Mataró
    • Contact: Berhanu Chimdi, Dr.
    • Principal Investigator: Berhanu Chimdi, Dr.
  • Santa Coloma de Gramenet, Spain, 08923
    • Hospital Fundació Esperit Sant
    • Contact: Daniel Troyano Escribano, Dr.
    • Principal Investigator: Daniel Troyano Escribano, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

High-risk patients according to the professional criteria (such as but not limited to: age, nutrition, body mass index, comorbidities, etc.) who are undergoing prophylactic mesh implantation to avoid surgical site infection after an emergency or urgent intra-abdominal laparotomy.

Description

Inclusion Criteria:

• Adult patients (18 years or older)
• Surgical procedure requiring urgent, primary median laparotomy, which are classified as "Class III/Contaminated" or "Class IV/Dirty-Infected" regarding the CDC classification.

These include but are not limited to:

• Vascular surgery
• Colon and rectum
• Hepatobiliary
• Gastrointestinal
• Gynecology
• Urology
• Abdominal Aortic Aneurysm (AAA) repair
• Right hemicolectomy
• Left hemicolectomy
• Sigmoidectomy
• Anterior resection
• Abdominoperineal amputation
• Exploratory laparotomy
• Cholecystectomy

• Cholecystectomy and choledocotomy

  • Written informed consent

Exclusion Criteria:

• Pregnancy
• Breast feeding
• Patients < 18 years old or patients who are still in the growth phase
• Contaminated and infected areas
• Hypersensitivity to silver
• Direct contact with the viscera
• Previous allergic reactions to components of the device
• Patient with previous laparotomy
• Transverse laparotomy
• Patients with previous hernia repair
• Simultaneous participation in another investigational clinical trial (drug or medical studies)
• Patients with active oncologic treatment (chemo and radiotherapy)
• Underlying autoimmune disease
• Recent cardiovascular complication
• Gynecology surgery
• Urology surgery
• Vascular surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Optilene® Silver Mesh Elastic; Prophylactic mesh in high-risk patients	Device: Prophylactic mesh; Prevention of incisional hernia after a prophylactic mesh in high-risk patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Infection (SSI) A2/A3 rate	SSIs remain a significant clinical problem as they are associated with substantial mortality and morbidity and impose severe demands on healthcare resources. Centers for Disease Control and Prevention Surgical Site Infection (SSI) Classification System differentiates Superficial SSI (A1), Deep Incisional SSI (A2) and Infection with involvement of organs/body cavities (A3). Only cases of A2 and A3 are considered for the Primary Outcome and are compared to rates from reference literature	at 6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative rate of of postoperative complications during the study period	Numbers of all postoperative complications such as mortality, burst abdomen, bowel obstruction, bulging, necrosis, fistula, wound dehiscence, hematoma, seroma, peritonitis are added to the overall complication rate that is observed over the postoperative course	at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up
Cumulative Surgical Site Infection (SSI) A2/A3 rate during the study period	Number of the Surgical Site Infection (SSI) (only A2 and A3) rate at every follow-up	at 1 month, 1 year and 2 year follow-up.
Incisional hernia (IH) rate during the study period	Incisional hernia (IH) is a protrusion of tissue that forms at the site of a healing surgical scar. Incisional hernia refers to abdominal wall hernia at the site of a previous surgical incision.	repeatedly at 6 months, 1 year and 2 year follow-up.
Length of hospital stay	Number of days the patient has to stay in hospital after the surgery	at discharge (approximately up to 10 days after surgery)
Development of Pain: Visual Analogue Scale (VAS)	This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".	at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score
Time to return to work	The number of days needed to return to work after the surgery of the individual patient is documented	at all postoperative examinations with a single value for each individual patient
Handling of the Optilene® Silver Mesh Elastic	The handling will be evaluated using a questionnaire (Likert-type scale) with the dimensions Tensile Strength, Absence of memory effect, Elasticity, Stiffness, Surface weight, Thickness, Ease of being fixed with suture, Ease of package extraction as well as an overall opinion in five evaluation levels (excellent=1, very good=2, good=3, satisfied=4, poor=5)	intraoperatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Daniel Troyano Escribano, Dr., Fundacio Hospital de l'Esperit Sant

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: urgent, primary median laparotomy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Aortic Diseases; Obesity; Aneurysm; Aortic Aneurysm; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity, Morbid; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: AAG-G-H-2126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No